BEUDAMED
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    NURSE'S ASSISTANT O.R. CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152023·Endo Carry-on Procedure Kit contains Intercept ...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890107540·Zirlux Titanium Abutment 4.5 mmH compatible wit...

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

    MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·March 19, 2013

    CODMAN EXTERNAL DRAINAGE SYSTEM II

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·March 2, 2011

    RIATA ST OPTIM ACTIVE-FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 11, 1997

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018